Closing of Flow Through Catheter

ABSTRACT

An assembly comprising a catheter package ( 1 ), a catheter ( 7 ) and a collecting bag ( 3 ) is provided. The assembly has means for preventing flow of liquid through the catheter during storage. A sealing element ( 11 ) closing the eyelets is provided. An extended cone-lock ( 23 ) in a telescopic catheter is also provided.

The invention relates to an assembly comprising a catheter stored in apackage and a urine collecting bag. The catheter is stored in a liquidswelling medium in the package. The catheter or package comprises meansfor closing the flow through the catheter prior to use.

BACKGROUND

Catheter packages exist in which a hydrophilic coated catheter is storedin liquid swelling medium. When such a catheter package is combined witha urine collecting bag into a catheter kit, it is undesirable that theliquid swelling medium enters the bag. This makes it uncertain how largean amount of liquid is present in the container or package for wettingthe catheter. If there is not enough swelling medium present then thecatheter may dry out. Furthermore, many types of swelling mediumevaporate into a crystalline structure which may clog the construction,thereby preventing liquid from flowing through the catheter and into theurine collecting bag when the catheter is to be used. Finally, swellingmedium in the urine collecting bag is perceived unhygienic, and for auser where hygiene is important such perception may deter him from usingthe product.

Thus, there exists a need for an assembly as described where it isprevented that liquid flows from the catheter and into the urinecollecting bag before use of the catheter assembly.

DESCRIPTION OF RELATED ART

International publication no. WO2011011023 discloses a catheter assemblyincluding a tubular member having a first end and a second end. Acatheter has a first end and a second end. At least a portion of thecatheter is disposed within the tubular member. The first end of thetubular member is openable by axial movement of the catheter. A sealingengagement is provided between the tubular member and the catheter.

SUMMARY OF THE INVENTION

The invention relates to an assembly with a package for a catheter, acatheter stored in a cavity and a urine collecting bag communicatingwith the catheter. The catheter is a hydrophilic coated catheter storedin liquid swelling medium. During storage, the liquid swelling mediumshould be prevented from travelling from the cavity through the catheterand into the collecting bag. Thus, this invention provides means forpreventing flow of liquid through the catheter during storage.

DETAILED DESCRIPTION OF THE INVENTION

In a first aspect, the invention relates to an assembly comprising acatheter package, a hydrophilic coated catheter and a urine collectingbag, the collecting bag being attached to or communicating with thecatheter so that, in use, urine is able to flow through the catheter andinto the collecting bag, the assembly comprising

-   -   a cavity in the package adapted for storing the hydrophilic        coated catheter and liquid swelling medium for wetting the        coating on the catheter; and    -   a liquid stop in the cavity or catheter so that the liquid        swelling medium is prevented from flowing from the cavity,        through the catheter and into the urine collecting bag during        storage.

By providing an assembly with a liquid stop in the cavity or catheter,liquid is prevented from flowing through the catheter during storage.This has the effect that the liquid swelling medium is prevented fromescaping from the cavity and furthermore prevented from soiling theurine collecting bag prior to use. Thus, the drawbacks mentioned aboveare eliminated.

In the following, whenever referring to the proximal end of an elementof the invention, the referral is to the end adapted for insertion.Whenever referring to the distal end of an element, the referral is tothe end opposite the insertion end. In other words, the proximal end isthe end closest to the user, when the catheter is to be inserted and thedistal end is the opposite end—the end furthest away from the user whenthe catheter is to be inserted.

The longitudinal direction is the direction from the distal to theproximal end. The transverse direction is the direction perpendicular tothe longitudinal direction, which corresponds to the direction acrossthe shaft of the catheter.

The catheter described in this application may be used as anintermittent urinary catheter.

The catheter comprises a main tubular part extending from the distal endto the proximal end. The tip is positioned in the proximal end of thecatheter and is provided as a rounded closed end of the tubeconstituting the main part of the catheter. The connector is provided inthe distal end and may in an embodiment comprise a flared end of thecatheter so that the diameter of the connector increases with respect tothe tubular part.

Usually catheters used as urinary draining devices are from size 8 FR tosize 18 FR. FR (or French size or Charriere (Ch)) is a standard gaugefor catheters, approximately corresponding to the outer circumference inmm. More accurately, the outer diameter of the catheter in mmcorresponds to FR divided by 3. Thus, 8 FR corresponds to a catheterwith an outer diameter of 2.7 mm and 18 FR corresponds to a catheterwith an outer diameter of 6 mm.

The catheters of this invention are prior to use provided with ahydrophilic coating so as to impart a low-friction insertion.

The invention provides a liquid stop in the cavity or the catheter. Thisliquid stop functions as means for preventing flow through the catheterduring storage. The liquid stop is adapted either to prevent flow ofliquid into the catheter, when the catheter is stored, or to preventflow of liquid through the catheter during storage. In the latter caseliquid is prevented from travelling from the proximal end of thecatheter and out through the distal end. However, when the catheter isto be used and is removed from the package then urine should be able toflow through the catheter from the proximal end to the distal end andfrom there into the urine collecting bag. Thus, when the catheter is tobe used, the liquid stop is inactivated. In other words, the liquid stopis only able to prevent liquid flow during storage and will allow liquidflow when the catheter is to be used.

The assembly can be in storage position and in use position. In storageposition the catheter is packed inside the cavity of the package andliquid flow from the cavity to the urine collecting bag through thecatheter is prevented due to the liquid stop. In use position, thecatheter is removed from the cavity of the package and liquid is able toflow from the proximal end of the catheter, through the catheter and outthrough the distal end of the catheter into the urine collecting bag.

The assembly of the invention comprises a urine collecting bagcommunicating with the catheter. In the simplest form, the collectingbag may be welded or glued directly onto the catheter. However, theurine collecting bag may also be attached through a connecting piece.

The urine collecting bag may be made of foil material, for examplePolyethylene, and may be able to contain a volume of up to approximately750 ml.

The liquid stop may comprise a closure preventing urine flowing into thecatheter through the eyelets, when the catheter is stored.

In one embodiment of the invention, the cavity of the package isprovided with a sealing element, which is adapted for sealing theeyelets to the catheter.

A closure or a sealing element at the eyelets is a simple solution thatis easy to incorporate. It also has the effect that liquid swellingmedium is completely prevented from entering into the catheter, thus therisk of crystalisation of the liquid swelling medium inside of thecatheter is alleviated.

The sealing element may be in form of an element of closed cell foam(e.g. PU-foam) provided with a hole for inserting the proximal end ofthe catheter with the eyelets. The dimension of the sealing element inthe longitudinal direction should be larger than the distance from theextreme proximal tip of the catheter to the most distal part of eyelets.This ensures that the sealing element covers the eyelets completely andthereby prevents liquid swelling medium from entering through theeyelets into the catheter.

A very soft polymeric material may also be used for the sealing element.

In one embodiment of the invention, the catheter is a telescopiccatheter comprising an outer catheter part and an inner catheter part,which are provided with a cone-lock between the two parts. The cone-lockmay be as described in the section: “Detailed Description of theDrawing”. In this embodiment, the sealing is provided as an extension ofthe cone-element, which may cooperate with a sealing element on an innersurface of a distal end of the outer catheter part to prevent liquidflow through the catheter. Alternatively, the extension may be providedwith a sealing element adapted for sealing on an inner surface of adistal end of the outer catheter part to prevent liquid flow through thecatheter.

The distal end of the outer catheter part may be provided with a handle.In this case, the sealing element may be provided at an inner surface ofthe handle. Alternatively or additionally the handle may be providedwith a reduced inner diameter with respect to the inner diameter of theouter catheter. This allows for a secure sealing while still allowingunimpeded movement of the inner catheter with respect to the outercatheter part.

In this embodiment, the inner catheter part as well as the outercatheter part is adapted for insertion into the urethra. This means thatboth catheter parts have dimensions within the regular French sizes—thatis between 8 FR and 18 FR. Furthermore, both catheter parts are providedwith hydrophilic coating.

The sealing ring may be made of TPE for example Santoprene (R).

The outer diameter of the extended conus lock should be smaller than theinner diameter of the outer part of the catheter. Otherwise, theextension will prevent movement of the outer catheter part with respectto the inner catheter part.

In an embodiment of the invention, the extension of the cone-lock may beprovided with outlet for the urine.

BRIEF DESCRIPTION OF THE DRAWING

FIGS. 1-4 illustrate an assembly according to the invention

FIG. 5 illustrates a closure of the eyelets by a foam element

FIG. 6 illustrates a telescopic catheter with an extended cone-lock inthe storage configuration i.e. when the assembly is in the storageposition

FIG. 7 illustrates a telescopic catheter with an extended cone-lock inthe extended (ready-to-use) configuration i.e. when the assembly is inthe use position.

DETAILED DESCRIPTION OF THE DRAWING

FIGS. 1-4 show in a stepwise sequence a catheter assembly 1 and how thecatheter is prepared for use. The different embodiments disclosed hereinmay be incorporated into the catheter assembly 1 by a person skilled inthe art. FIG. 1 shows the assembly in the storage position.

The catheter assembly comprises a container 2 and a cover 3 for closingoff and covering an opening of the container 2. The container 2 definesthe cavity 2 a for storing the catheter. The cover 3 is removed bytwisting the cover 3 around along the arrow as shown in FIG. 1. Thisreleases the cover 3 from the threaded coupling 4 a, 4 b as shown inFIG. 2, which exposes a urine collecting bag 5 which has been foldedinside the cover 3. The cover 3 may be discarded or saved for laterre-closing of the catheter assembly 1.

The urine collecting bag 5 is unfolded exposing a catheter handle 6around which it was folded as seen in FIG. 3. The handle 6 is attachedto the distal end 7 of a catheter 8. The handle is coupled with a neckportion 9 of the container, which defines an opening of the container 2through which the catheter 8 can be inserted and retrieved.

Finally, the catheter 8 and the urine collecting bag 5 are removed fromthe container 2 by pulling the handle 6 as shown in FIG. 4, whereby thecatheter 8 is ready for insertion into the urethra. Thus, FIG. 4 showsthe assembly in the use position.

The catheter is hydrophilic coated and stored together with a swellingmedium (FIG. 5) in the container 2.

FIG. 5 illustrates a cross-section of a part of the catheter assembly 1shown in FIG. 1 to FIG. 4. The assembly 1 has a cavity 2 a including acatheter 8 and the liquid swelling medium 9. The catheter is providedwith eyelets 10, which in use leads the urine from the bladder andthrough the catheter. A sealing element 11 is inserted in the cavity 2a, so that liquid swelling medium 9 contained in the cavity 2 a isprevented from entering into the catheter 7, through the eyelets 10. Thesealing element 11 may be made of closed cell foam or a soft polymericmaterial. The sealing element 11 is provided with a hole 12 adapted insize to the outer dimension of the catheter.

FIGS. 6 and 7 illustrate a telescopic catheter 20. In FIG. 6, thecatheter is shown in the collapsed configuration (the storedconfiguration) and in FIG. 7 the catheter is shown in the extendedconfiguration, when the catheter is ready to be used.

The catheter comprises an inner catheter part 21 and an outer catheterpart 22 that are connected through a cone-lock 23. The cone-lock isattached to the distal end 21 a of the inner catheter part by anattachment part 24 extending into the catheter part. A first stop 25 isprovided at the distal end 21 a of the inner catheter part. Distally ofthis first stop, the cone-lock comprises a cone-element 26 followed by asecond stop 27. Between the two stops, a locking element 28 is provided.This locking element engages frictionally with the inner surface of theouter catheter part, when the locking element 28 is positioned at thefirst stop 25. At the second stop 26, the locking element 28 is notengaged with the inner surface of the outer catheter part, thus when theelement 28 is at this position, the inner catheter part 21 can move withrespect to the outer catheter part 22. These parts, the two stops 25,27, the cone-element 26, the attachment part 24 and the locking element28 constitutes a cone-lock known from the prior art. However, thisinvention provides an extension of this cone-lock generally indicated at30. The extension is provided with a urine outlet hole 31 communicatingwith the inner channel 29 through the cone-lock. This allows urine to bedrained through the catheter when the catheter is in use. In theproximal end 21 b, the inner catheter part 21 is provided with eyelets32 for letting urine enter into the catheter.

The outer catheter part 22 is provided with a handle 33 at its distalend 22 a. A urine collecting bag (not shown) may be attached to orattachable to the handle 33 so as to collect the urine. The handle 33 isprovided with a sealing element 34 that cooperates with the extension 30to prevent liquid from flowing through the catheter and out through thehandle 33, when the catheter is stored.

When the catheter is stored (shown in FIG. 2), the inner catheter partis almost completely entered into the outer catheter part. The lockingelement 28 is positioned at the second stop 27, so that the outercatheter part 22 can move with respect to the inner catheter part 21. Inthis configuration of the catheter, any liquid (for example liquidswelling medium) entering into the catheter through the eyelets will beable to enter all the way through the inner catheter part 21, throughthe inner channel 29 through the cone-lock and out through the urineoutlet hole 31 in the extension 30. However, the sealing element 34 willprevent it from flowing out through the distal end 33 a of the handleand into a collecting bag (not shown) that is attached thereto.

When the catheter is to be used, it is removed from the package(indicated dashed at 40 in FIG. 2), and the catheter is extended to itsfully extended position. In this configuration of the catheter, urinecan flow into the catheter through the eyelets 32, through the innercatheter part 21, through the inner channel 29 of the cone-lock, throughthe outer catheter part 22 and out through the handle 33 to a collectingbag (not shown) attached thereto. This is because, in the extendedposition, the sealing element 34 is disengaged from the extension 30.

1. An assembly comprising a catheter package, a hydrophilic coatedcatheter and a urine collecting bag provided to collect urine dischargedfrom the assembly comprising a cavity formed in the package and adaptedfor storing the hydrophilic coated catheter and liquid for wetting ahydrophilic coating on the hydrophilic coated catheter; wherein thehydrophilic coated catheter is a telescopic catheter comprising an outercatheter part that slides relative to an inner catheter part, the outercatheter part is connected by a cone-lock to the inner catheter part,and the Lone-lock has an extension element, wherein one of a distal endof the outer catheter part and the extension element is provided with asealing element that, in a collapsed position of the telescopiccatheter, forms a seal between the distal end of the outer catheter partand the extension element to prevent liquid from travelling from exitingthrough the distal end of the catheter.
 2. The assembly according toclaim 1, wherein the distal end of the outer catheter part is providedwith a handle and the sealing element is attached to the handle.
 3. Theassembly according to claim 1, wherein the sealing element is attachedto the extension element.
 4. The assembly according to claim 1, whereinthe handle has an inner diameter that is smaller than an inner diameterof the outer.
 5. The assembly according to claim 1, wherein theextension element comprises one or more outlets for the urine.
 6. Theassembly according to claim 1, wherein the extension element has anouter diameter that is smaller than an inner diameter of the outercatheter part.
 7. The assembly according to any of the preceding claims,wherein the catheter is a telescopic catheter comprising an outercatheter part and an inner catheter part connected through a cone-lockwith an extension element and wherein a distal end of the outer catheterpart is provided with a handle with a sealing element that, in acollapsed position of the telescopic catheter, cooperates with theextension element to provide a sealing preventing liquid from flowingthrough the catheter.
 8. The assembly according to any of the precedingclaims, wherein the catheter is a telescopic catheter comprising anouter catheter part and an inner catheter part connected through acone-lock with an extension element and wherein the extension element isprovided with a sealing element that, in a collapsed position of thetelescopic catheter, cooperates with a handle provided at a distal endof the outer catheter part to provide a sealing preventing liquid fromflowing through the catheter.
 9. The assembly according to any of thepreceding claims, wherein the handle has a reduced inner diameter withrespect to the inner diameter of the outer catheter part.
 10. Theassembly according to any of the preceding claims, wherein the extensionelement comprises one or more outlets for the urine.
 11. The assemblyaccording to any of the preceding claims, wherein the extension elementhas an outer diameter smaller than the inner diameter of the outercatheter part.